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类风湿关节炎一线肿瘤坏死因子抑制剂的12年保留率:来自本地登记处的真实数据

Twelve-Year Retention Rate of First-Line Tumor Necrosis Factor Inhibitors in Rheumatoid Arthritis: Real-Life Data From a Local Registry.

作者信息

Favalli Ennio Giulio, Pregnolato Francesca, Biggioggero Martina, Becciolini Andrea, Penatti Alessandra Emiliana, Marchesoni Antonio, Meroni Pier Luigi

机构信息

Gaetano Pini Institute, Milan, Italy.

Experimental Laboratory of Immunological and Rheumatologic Researches, IRCCS Istituto Auxologico Italiano, Milan, Italy.

出版信息

Arthritis Care Res (Hoboken). 2016 Apr;68(4):432-9. doi: 10.1002/acr.22788.

Abstract

OBJECTIVE

To evaluate the 12-year survival of the first tumor necrosis factor inhibitor (TNFi) treatment in a cohort of rheumatoid arthritis (RA) patients, comparing the between-groups discontinuation rates for infliximab, etanercept, and adalimumab.

METHODS

RA patients treated with their first TNFi were investigated from a local registry. Before and after adjusting for propensity scores, overall and by individual TNFi 12-year drug retention was evaluated. Drug survival rates were calculated using the Kaplan-Meier method and compared by the Cox extended model. Subanalyses were performed according to concomitant methotrexate (MTX) and discontinuation reasons.

RESULTS

Of 583 patients, 222 were treated with infliximab, 179 with etanercept, and 182 with adalimumab; 33.7% and 26% discontinued the first TNFi because of inefficacy or adverse events, respectively. The overall 12-year drug survival rate for the unmatched population was 23.4%. In the propensity score-adjusted population, the hazard ratio (HR) for treatment discontinuation was significantly greater for adalimumab and infliximab versus etanercept (HR 2.89 [95% confidence interval (95% CI) 2.2-3.78] and HR 2.56 [95% CI 1.92-3.4], respectively), and no difference was found between and for adalimumab versus infliximab (HR 1.16 [95% CI 0.91-1.47]). The incidence of withdrawal due to secondary inefficacy was stable from 3 to 12 years for etanercept, but progressively increased for the monoclonal antibodies. Concomitant MTX significantly increased the survival of both adalimumab and etanercept (HR 1.48 [95% CI 1.18-1.86]).

CONCLUSION

The overall 12-year drug survival rate was 23.4%, being significantly higher for etanercept than adalimumab and infliximab. Etanercept discontinuations for inefficacy did not increase from 3 to 12 years. Concomitant MTX increased adalimumab and etanercept drug survival.

摘要

目的

评估一组类风湿关节炎(RA)患者首次使用肿瘤坏死因子抑制剂(TNFi)治疗的12年生存率,比较英夫利昔单抗、依那西普和阿达木单抗组间停药率。

方法

从当地登记处调查接受首次TNFi治疗的RA患者。在调整倾向得分前后,评估总体及各TNFi的12年药物保留率。使用Kaplan-Meier方法计算药物生存率,并通过Cox扩展模型进行比较。根据是否联合使用甲氨蝶呤(MTX)及停药原因进行亚组分析。

结果

583例患者中,222例接受英夫利昔单抗治疗,179例接受依那西普治疗,182例接受阿达木单抗治疗;分别有33.7%和26%的患者因疗效不佳或不良事件停用首次使用的TNFi。未匹配人群的总体12年药物生存率为23.4%。在倾向得分调整后的人群中,阿达木单抗和英夫利昔单抗治疗停药的风险比(HR)显著高于依那西普(分别为HR 2.89 [95%置信区间(95%CI)2.2 - 3.78]和HR 2.56 [95%CI 1.92 - 3.4]),阿达木单抗和英夫利昔单抗之间未发现差异(HR 1.16 [95%CI 0.91 - 1.47])。依那西普因继发性疗效不佳导致的停药发生率在3至12年保持稳定,但单克隆抗体的停药发生率逐渐增加。联合使用MTX显著提高了阿达木单抗和依那西普的生存率(HR 1.48 [95%CI 1.18 - 1.86])。

结论

总体12年药物生存率为23.4%,依那西普的生存率显著高于阿达木单抗和英夫利昔单抗。依那西普因疗效不佳导致的停药率在3至12年未增加。联合使用MTX提高了阿达木单抗和依那西普的药物生存率。

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